Quality Assurance and Management of HIV Counselling and Testing of HIV in HPTN 071/PopART study

At Zambart, Quality Counselling and Testing of HIV means providing services that meets the needs of clients and service providers in a professional manner within the resources available in line with the National Guidelines and protocols. Thus we place high value on the competence of our providers and therefore only qualified counsellors trained according to National Guidelines conduct our HIV Counselling and Testing.

HPTN 071/PopART counsellors are all trained Psycho-Social Counsellors and have also been trained in House Hold Counselling and Testing for HIV. The role of counsellors who carry out the HIV Counselling and Testing is very paramount because they play an essential role in the intervention being given in a community. To gain trust and confidence of our clients, all our HIV Counselling and Testing is done in utmost confidentiality. We only release results to concerned clients and no other. All registers, documents, with client’s names and results are kept under lock and key accessed only by authorised personnel.

For the HPTN 071/PopART study, an External Quality Assurance System (EQA) is in place. This entails working closely with the Ministry of Community Development, Mother Child Health (MCDMCH) and Virology Laboratory at University Teaching Hospital (UTH) in providing EQA. Our central laboratory takes the centre stage in planning and carrying out EQA using Proficiency Panel Testing for all our counsellors conducting HIV Counselling and Testing. Proficiency testing helps to ensure accuracy, precise and valid results. We also carry out 10 % random retesting to determine accuracy of the results and resolve issues where problems may have been identified. This is from the recommendation from the national Virology Laboratory.

In HPTN 071/PopART, quality assurance and management of HIV counselling and testing is a coordination of various processes which are essential to the outcomes of the study. Quality Assurance is a systematic approach to planning, implementation, monitoring, assessing and improving quality service to our clients on a continuous basis to best serve our communities in which our research is being carried out. HPTN 071/PopART, is a high-profile and huge clinical study into HIV prevention, which if successful, will be a game-changing study. It will change the way policy –makers and governments approach HIV prevention. Therefore, quality assurance management of HIV Counselling and Testing in a clinical research like HPTN 071/PopART study is very integral to the success and outcome of the study.

Quality Assurance in PopART is a coordinated process from beginning to end

The process begins with the Community HIV care Providers (CHiPs), who are the study fore-runners, and conduct door-to-door HIV counselling and testing in the communities. They conduct HIV rapid tests according to the study protocol, Standard Operating Procedures (SOP)) and are routinely monitored by CHiPs Supervisors. To maintain quality and standards, the CHiPs meet monthly for review meetings at which they report all challenges and incidences concerning HIV Counselling and Testing to their Supervisor.

In addition, they have one-on-one counselling supervision sessions with a mentor every month. As a research-based organisation, this is very important because having a competent cadre of counsellors that deliver a high quality service ensures that study clients’ needs and rights are protected and not compromised.

The CHiPs Supervisors ensure that the CHiPs have all the necessary commodities and testing kits to perform HIV Counselling and Testing when they are out in the communities. At no time can they run out of testing kits while in the field as this would compromise on the quality of service. The CHiPs Supervisor also ensures that the kits are not damaged or expired – a rigorous check process is in place to ensure this at all times because it is very important that only quality tests kits are used in order for use clients’ results must be accurate.

The CHiPs Supervisor at times accompanies the CHiPs in the field to directly observe what the CHiPs as they work in the community. Because HPTN 071/PopART is a community-based research and client satisfaction is very important to the study’s success, we want to be part of the community and this means respecting the community values and being part of the community. As such, from time to time, the CHiPs Supervisor goes alone in the community and asks from the community what they think and feel about the work the CHiPs are conducting in the community. This is very important in knowing what the community feels or thinks about the study. It also serves as a resource in knowing whether the community have the right information about the study in line with good clinical practice.

We want our services to be of respect and acceptable in the community we are working in.

The District Intervention Coordinator (DIC) plays a very important role because they are the record keepers of all HIV Counselling and Testing; they resolve all challenges and incidences regarding HIV Counselling and Testing. If there are any discrepancy results or discordant results, the DIC works closely with the Quality Assurance Manager to resolve the issue. Accuracy and reliability of diagnostic testing is critical to PopART

All we want is to give accurate results to our clients and for us Standard Operating Procedures, Protocols and National Guidelines are paramount.

The DIC conducts Internal Quality Control every time he receives new testing kits and conducts Internal Quality Control every week on the kits being used by the CHiPs. The DIC also evaluates all the CHiPs, offers support and gives recommendation for further training where needed. In addition, the DIC is also able to obtain feedback from the community on HIV Counselling and Testing.

Pop ART is about early ART initiation for all our clients that test HIV positive in our Arm A sites. We want to be sure that only clients who are HIV positive are started on treatment. In order to ensure this, we have a cadre of clinical nurses at all Arm A sites whose key role is to re-test all HIV positive clients with a CD4 count of 500 and above who come for enrolment. They re-test the clients according to the testing protocols and National Guidelines. If there are discrepancies, they follow the National Guidelines in resolving the issue until the true status of the client is determined that’s when the client can be enrolled for ART or be dropped out if found to be negative. This is very cardinal.

Every site receives supportive counselling supervision visits from the Quality Assurance Manager every two months to review HIV Counselling and Testing and resolve all challenges and incidences. Training needs are identified and recommended and stress management plans are shared and seen to fulfilment. In conclusion we would say, Quality Assurance is a systematic approach to planning, implementation, monitoring, assessing and improving quality service to our clients on a continuous basis to best serve our communities.